DeviceClearance

MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER— 510(k) K071011

Substantially Equivalent

Braemar, Inc.

FDA 510(k) clearance K071011 for MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER, Substantially Equivalent on 2007-04-27. Applicant: Braemar, Inc.. Device class: 2.

Clearance details

Applicant
Braemar, Inc.
Product code
Code MWJ
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Eagan, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.